Novavax Begins COVID-19 Vaccine Trial for Children 6 Months Through 11 Years
This study looks to identify safety, efficacy of the vaccine in the youngest pediatric populations.
Novavax announced today it has begun its Hummingbird trial, a phase 2b/3 study evaluating its Novavax COVID-19 vaccine, NVX-CoV2373 (Nuvaxovid), in children aged 6 months through 11 years, followed by a booster at 6 months after the primary vaccination series.
"We are excited to begin the Hummingbird trial to study Nuvaxovid's efficacy in children as young as six months through age 11," Novavax CEO Stanley Erck, said. "With a successful trial, we may have the opportunity to offer our COVID-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic."
The study will evaluate the efficacy of 2 doses of their vaccine in infants (six through 23 months of age), toddlers (2 through 5 years) and children (six through 11 years). The trial is an age de-escalation trial and age groups will be tested sequentially. Participants have begun dosing in the six to 11-year-old age group. The trial will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.
They are seeking to enroll up to 3600 participants in the United States, Mexico, Colombia, Argentina, Spain, United Kingdom, South Africa, Philippines, and Brazil.
Back in July, the FDA granted Novavax an Emergency Use Authorization (EUA) for their vaccine against COVID-19 in adults aged ≥18 years old. The EUA was based on findings from the phase 3 pivotal PREVENT-19 trial, in which investigators assessed NVX-CoV2373 in approximately 30,000 participants aged ≥18 years old in the US and Mexico. PREVENT-19 data showed a 90.4% vaccine efficacy (95% CI, 83.8 - 94.3; P <.001) versus placebo.
The Initial results for the Hummingbird trial are expected in the first quarter of 2023.